A fully integrated assay and platform for detecting Clostridium difficile.

描述（由申请人提供）：本项目的主要目标是开发一种即时诊断检测方法和平台，用于检测人类粪便中的艰难梭菌。另外两个目标是检测艰难梭菌B1/NAP/027的高毒力菌株，并从医疗器械拭子中检测艰难梭菌孢子。艰难梭菌相关疾病（CDAD）现在是美国最常见的医疗保健获得性感染，估计每年有300万例CDAD病例，每年花费10 - 32亿美元。在住院时间不超过两周的患者中，艰难梭菌感染的频率估计为13%，而在住院时间超过四周的患者中，这一比例为50%。将艰难梭菌检测带到护理点环境将有助于对患者进行更及时的治疗，并减少疾病传播的风险。监测艰难梭菌污染表面的能力是这个项目的独特贡献。国家和全球的医院、疗养院和康复设施将欢迎能够监测艰难梭菌及其孢子造成的环境污染负担，采取相应的感染控制程序，并核实这些变化是否取得了预期的结果。Claremont BioSolutions （CBio）正在开发一种集成的一次性检测设备和平台，该设备基于我们专有的用于样品制备的一次性检测试剂盒PureLyse(R)，该试剂盒可以在不到5分钟的时间内机械裂解细胞并提取DNA，并具有快速等温核酸扩增系统，两者都嵌入一次性设备中。该平台提供扩增产物的检测，并基于CBio的便携式FluoriSense荧光计。PureLyse(R)腔室将安装在我们的新型OmniValve中，以创建一种适合快速高效制造的检测设备。

DESCRIPTION (provided by applicant): The primary goal of this proposed project is to develop a point-of-care diagnostic assay and platform for the detection of Clostridium difficile from human stool. Two additional goals are to detect the hypervirulent strain of C. difficile B1/NAP/027 and to detect C. difficile spores from swabs of medical devices. C. difficile associated disease (CDAD) is now the most common healthcare acquired infection in the United States with an estimated three million CDAD cases per year, costing $1- 3.2 billion per year. The frequency of C. difficile acquisition is estimated to be 13% in patients with hospital stays of up to two weeks, and 50% in those with hospital stays longer than four weeks5. Bringing detection of C. difficile to the point-of-care setting will facilitate more timely treatent for patient, as well as reduce the risk of spread of the disease. The capability to monitor surfaces for C. difficile contamination is a unique contribution of this project. Hospitals, nursin homes, and rehabilitation facilities, both nationally and globally, will welcome the ability to monitor the burden of environmental contamination by C. difficile and its spores, respond with infection control procedures accordingly, and verify that those changes have achieved the desired result. Claremont BioSolutions (CBio) is developing an integrated disposable assay device and platform that is based on the combination of our proprietary disposable cartridge for sample preparation, PureLyse(R), that can mechanically lyse cells and extract DNA in less than five minutes, with a rapid isothermal nucleic acid amplification system, both embedded into a disposable device. The platform provides detection of the amplification product and is based on CBio's portable FluoriSense" fluorometer. The PureLyse(R) chamber will be mounted within our novel OmniValve" to create an assay device that lends itself to rapid and efficient manufacturing.